Jet-injection assisted photodynamic therapy for superficial and nodular basal cell carcinoma: A pilot study

IF 2.2 3区医学 Q2 DERMATOLOGY Lasers in Surgery and Medicine Pub Date : 2024-05-28 DOI:10.1002/lsm.23793

Leore Lavin, Andrés M. Erlendsson, Saud Aleissa, Abdullah Aleisa, Christian Menzer, Stephen Dusza, Miguel Cordova, Hesham Alshaikh, Rohan Shah, Alexander Pan, Kwami Ketosugbo, Sharif Hosein, Erica Lee, Kishwer Nehal, Katrine Togsverd-Bo, Merete Haedersdal, Anthony Rossi

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Abstract

Background

Photodynamic therapy (PDT) with topical δ-Aminolevulinic acid (ALA) has efficacy in treating basal cell carcinoma (BCC) but is limited by incomplete penetration of ALA into the deeper dermis. This prospective open-label pilot trial investigated the safety and efficacy of photosensitizer jet injection for PDT (JI-PDT) for BCC treatment. It was performed with 15 patients (n = 15) with histologically confirmed, untreated, low-risk nodular BCCs at a single institution.

Methods

For the intervention, JI-PDT patients (n = 11) received two sessions of jet-injected ALA with PDT separated by four to 6 weeks. To further understand treatment technique, another group of patients (n = 4) received jet-injected ALA followed by tumor excision and fluorescence microscopy (JI-E). Treatment tolerability was assessed by local skin responses (LSR) score at five distinct time intervals. Fluorescence microscopy assessed protoporphyrin IX penetration depth and biodistribution within the tumor. At the primary endpoint, tumor clearance was evaluated via visual inspection, dermoscopy and reflectance confocal microscopy. Postinjection and postillumination pain levels, and patient satisfaction, were scored on a 0−10 scale.

Results

Fifteen participants with mean age of 58.3, who were 15/15 White, non-Hispanic enrolled. The median composite LSR score immediately after JI-PDT was 5 (interquartile range [IQR] = 3) which decreased to 0.5 (IQR = 1) at primary endpoint (p < 0.01). Immunofluorescence of excised BCC tumors with jet-injected ALA showed photosensitizer penetration into papillary and reticular dermis. Of the 13 JI-PDT tumors, 11 had tumor clearance confirmed, 1 recurred, and 1 was lost to follow-up. 1/11 patients experienced a serious adverse event of cellulitis. 70% of patients had local scarring at 3 months. Patients reported an average pain level of 5.6 (standard deviation [SD] = 2.3) during jet injection and 3.7 (SD = 1.8) during light illumination.

Conclusions

Jet injection of ALA for PDT treatment of nodular low-risk BCC is tolerable and feasible and may represent a novel modality to improve PDT.

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浅表和结节性基底细胞癌的喷射注射辅助光动力疗法：一项试点研究。

背景：局部使用δ-氨基酮戊酸（ALA）的光动力疗法（PDT）对治疗基底细胞癌（BCC）有一定疗效，但由于ALA不能完全渗透到真皮深层而受到限制。这项前瞻性开放标签试验研究了光敏剂喷射注射光导疗法（JI-PDT）治疗 BCC 的安全性和有效性。试验在一家医疗机构进行，15 名患者（n = 15）经组织学证实患有未经治疗的低风险结节性 BCC：在干预过程中，JI-PDT 患者（n = 11）接受了两次喷射注射 ALA 和 PDT 治疗，每次间隔 4 到 6 周。为进一步了解治疗技术，另一组患者（n = 4）在接受喷射注射 ALA 后进行肿瘤切除和荧光显微镜检查（JI-E）。治疗耐受性通过五个不同时间间隔的局部皮肤反应（LSR）评分进行评估。荧光显微镜评估原卟啉 IX 在肿瘤内的穿透深度和生物分布。在主要终点，通过目测、皮肤镜和反射共聚焦显微镜评估肿瘤清除情况。注射后和照射后疼痛程度以及患者满意度按0-10级评分：15名参与者的平均年龄为58.3岁，其中15/15为白人，非西班牙裔。JI-PDT治疗后的LSR综合评分中位数为5（四分位间距[IQR] = 3），在主要终点时降至0.5（IQR = 1）（P 结论：JI-PDT治疗后的LSR综合评分中位数为5（四分位间距[IQR] = 3），在主要终点时降至0.5（IQR = 1喷射注射 ALA 用于 PDT 治疗结节性低风险 BCC 是可耐受和可行的，可能是一种改进 PDT 的新方法。

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来源期刊

Lasers in Surgery and Medicine 医学-外科

CiteScore

5.40

自引率

12.50%

发文量

119

审稿时长

1 months

期刊介绍： Lasers in Surgery and Medicine publishes the highest quality research and clinical manuscripts in areas relating to the use of lasers in medicine and biology. The journal publishes basic and clinical studies on the therapeutic and diagnostic use of lasers in all the surgical and medical specialties. Contributions regarding clinical trials, new therapeutic techniques or instrumentation, laser biophysics and bioengineering, photobiology and photochemistry, outcomes research, cost-effectiveness, and other aspects of biomedicine are welcome. Using a process of rigorous yet rapid review of submitted manuscripts, findings of high scientific and medical interest are published with a minimum delay.